Information Technology & Services - Hyderabad, Telangana, India
We are Expertized in Implementation and Validation of Below SystemsAutomated manufacturing equipmentAnalytical laboratory Systems (LIMS, CDS, SDMS, Standalone Systems)Process control systems (DCS, DAS)Process Analytical Systems Manufacturing Execution SystemsEnterprise Resource Planning Systems Clinical Trials Data Management SystemsVigilance Systems and Document Management Systems. Implementation of Computerized System Life Cycle with 21 CFR part 11 Compliance and EU Annex 11 Compliance.Data Integrity and Regulatory Gap Analysis for Computerized Systems.Remediation for Computerized Systems.Periodic Review of Computerized SystemsDecommission of Computerized SystemsComputerized System AuditsImplementation of IT Policies and SOPChange controls and Deviations managementQualification of EquipmentSpreadsheet Validation.Infrastructure QualificationCreation of CSV Procedures and Templates
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